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Executives

Lonnie Moulder - CEO and Director

Mary Lynne Hedley - President and CFO

Analysts

Robyn Karnauskas - Deutsche Bank

TESARO, Inc. (TSRO) Deutsche Bank BioFEST Conference December 2, 2013 2:15 PM ET

Question-and-Answer Session

Robyn Karnauskas - Deutsche Bank

Good afternoon, thanks for joining us. For those of you who are on the webcast, my name is Robyn Karnauskas. I am one of the analysts here at Deutsche Bank. Next we have TESARO, and from TESARO we have the CEO, Lonnie Moulder; and we have Mary Lynne Hedley, President and CFO. So thank you both for joining us. And we are all very excited and awaiting. I have been asked by everyone today where is the data, where is the data for Rolapitant? So everyone is really excited about that.

I thought I’ll start off with Rolapitant, since that is the focus. I had an investor ask me today, who is here in the room, and I get this question a lot so I thought I would ask it to you again. Why do you think Merck has not taken more share, can you just remind people why they’ve only taken 20% share in NK1 market?

Lonnie Moulder

Well if we step back to 2003 when Merck’s EMEND oral aprepitant was launched, the first NK1 receptor antagonist. It was a drug that had a three day oral regimen associated with it, a new class. And I think having had the opportunity at MGI Pharma to be involved with the launch of Aloxi at the same time, we observed in the chemotherapy induced nausea and vomiting space, the CINV vomiting space what Merck was doing relative to a commercial effort. They had taken a small group of their urology sales force and they repurposed it to oncology. They conservatively put forward a marketing program and some advertising, some basics.

But overtime it was clear that we were consistently, although we weren’t competitors because Aloxi was a 5-HT3 receptor antagonist and in fact the majority of the NK1 receptor used, Merck EMEND’s used is in combination with Aloxi. What we watched is, we probably had a sales force fulltime equivalent, at least double what they had and had a sales and marketing spend that was triple what Merck had put behind their brand. And I can't speculate necessarily as to why their level of spending and support was at that point in time, but clearly with that commercial support and their complicated oral regimen the drug really did not have an opportunity to ramp up.

So today it has substantial penetration in patients that are receiving cisplatin regimens. Those of you that follow this area closely, you may know that the guideline suggests that every patient that receives cisplatin should receive an NK1 receptor antagonist to or top of the standard of care. But the same is true for all breast cancer patients receiving anthracycline and cyclophosphamide combinations, and they’ve never really penetrated that. And a lot of it has to do with their initial launch. Some of the large oncology clinical networks will tell you that Merck had not partnered from a business perspective.

In the 5-HT3 marketplace, it was very important to have contracts in place. So Glaxo had a drug called Zofran, we at MGI had Aloxi, Roche had Kytril and all of us had performance-based contracts to try and drive share. We had some differentiation with our product and a very strong contract with Aloxi. So it ultimately gathered in greater than a 50 share. Merck never really got involved in that kind of business partnering. So I think all of that in combination has limited the uptake of the drug even though the guideline suggests a much larger patient population should receive an NK1 receptor antagonist.

Robyn Karnauskas - Deutsche Bank

Okay that’s helpful. In between the three trials, can you remind us again how the percentage of women might differ, what are the requirements include women between the three trials? And what other differences in the patient mix might we expect between the three ongoing studies?

Mary Lynne Hedley

For the HEC study, so these are patients receiving cisplatin-based chemotherapy. Those studies are typically comprised of patients having lung cancer, and that’s the majority of patients, and then other urogenital cancers. So we usually see about 60% men, 40% women in those studies. That would be typical. In the MEC study, now this study we have 50% of the patients who are receiving anthracycline and cyclophosphamide combinations. So automatically right there, and that’s almost all breast cancer patients, so automatically right there 50% of the women just from that part of the study are -- 50% of the people are women. And so then if you take the other half and you say, I don’t know maybe 50% are carboplatin-based primarily so that’s long ovarian other urogenital cancers. So maybe you get another 25% or half of those patients, so 75%-80% of the patients in the MEC studies, typically in that kind of a design would end up being female.

Robyn Karnauskas - Deutsche Bank

Okay. And any other differences in patient mix that we might expect?

Mary Lynne Hedley

From a gender perspective?

Robyn Karnauskas - Deutsche Bank

Well just, as far as…

Mary Lynne Hedley

Now that typical, again mostly long in the HEC and that will be 50% breast in the MEC and then the other -- and maybe about 25% lung and then the other 25% of mix.

Robyn Karnauskas - Deutsche Bank

And another question I get a lot is what happens if one of the HEC studies is positive for nausea and one is not or one of them -- or the MEC study is positive on nausea and the other two do not, what do you think the chances are that you’ll see different results in the different studies? And then what happens if you see different results, how does that -- how do doctors interpret that?

Mary Lynne Hedley

Right, so what would -- I think first of all it’s important to point out that the indication statement so the drug is approved for the prevention of chemotherapy induced nausea and vomiting. So that statement is based on the complete response endpoint, it has nothing to do with the secondary endpoints, which includes significant nausea. So that indication statement would appear in the package insert if we hit the CR endpoint, complete response endpoint. Complete response is no emesis and no use of rescue medication.

So from a physician and prescribers’ perspective, there is no difference in that indication statement than in the aprepitant indication statement. So where does the significant nausea data appear in the package insert and why is it useful to us potentially. That appears in the clinical section of the package insert. So if you went through aprepitant’s package insert and you went to the clinical section you would see broken out there for each of their two Phase 3 HEC studies the primary endpoint of complete response and then all the secondary endpoints.

And what you would see in aprepitant’s package insert is complete response and the P-value, obviously successful. And then you would see their secondary endpoints that include no emesis and they were statistically significant and no significant nausea and they were not statistically significant. Okay. So they still have an indication for -- so that’s important.

So for us if we had one trial be positive for nausea and one trial be negative, the indication statements are same, it appears in the clinical section of the package insert in those tables. So that’s the difference in terms of how I would expect it to actually play out from a approvability perspective and from an indication perspective, there is no impact. It’s just is the difference as it appears in the clinical section in that table where you see secondary endpoints and the P-value will be indicated. So if it’s positive for one it will be indicated as positive for one, the P-value will be listed, if it’s negative for one trial it will say not statistically significant.

Robyn Karnauskas - Deutsche Bank

How would it impact use though, if all trials are positive versus one, how will that impact the use?

Lonnie Moulder

Yes if you think about this, first of all, in the hierarchy the goal is successful Phase 3 outcome and an approved drug. What do we do with approved drug in-hand regardless of the deltas in the endpoints or the percent difference between control and our drug as long as we achieve significance than we have an approved drug. And whether we have a statistically significant difference in nausea or not we have an approved drug that has a long half life, that if it’s given just part of the chemo in either in oral or an IV forms, the IV with a plan to launch about a year after the oral will protect the patients potentially for the full five days. That was the Aloxi proposition that obtained a 50% market share along with business relationships with community oncology. So we have that long half life that sets us apart from aprepitant.

We’ll have an IV and an oral whereas right now one other potential competitor is than the Tualatin product is only developed as an oral and that’s only 20% of the market opportunity. In addition, it’s clear that we have differentiation from a CYP3A4 drug interaction standpoint. Now clearly all physicians are not familiar with drug interactions, I would tell you though that there is polypharmacy there are comorbidities with cancer patients and they’re taking many drugs. And it’s hard to protect since aprepitant is an inducer and inhibitor which is actually going to happen. And we know we’re clean from that standpoint. And I think that’s an important safety consideration.

So not only the long half life the convenience of once a day oral, once a day IV but there is lack of CYP3A4 drug interactions we have a differentiated product that I think sets us up nicely along with our business relationships with community oncology to have pathways go in place that follow the guidelines. And what do the guidelines say, the guidelines say every patient receiving cisplatin, every breast cancer patient receiving an anthracycline and cyclophosphamide combination should receive an NK1. Well, that alone is something approaching 4 million annual doses potentially.

In addition for MEC regimens, moderately emetogenic chemotherapy regimens, an NK1 receptor antagonist should be considered under the guidelines. And we know women receiving carboplatin are at high risk. So if you put that into the market mix there are 5 million potential doses. We have a drug that has some differentiation, has this long half life that really leads to a feeling of comfort for the nurses and physicians that they give a dose that protects the patient for five full days. And we have a plan to have a business relationship in place with community oncology, many of those large community oncology networks having done our Phase III program for us.

So, we’re well positioned, give us that approved drug and we think we can make it a significant brand, we’re quite bullish on that. Now, what if we have this nausea benefit, I suspect there are people because you’re not going to get a 100% market penetration with any drug, there are people that if we have some other hook they’re likely to line up for Rolapitant, so that’s how we see it.

Robyn Karnauskas - Deutsche Bank

So even if there is a mix, is a result of between if you get all of them for the, sort of the other hook that percentage that…

Lonnie Moulder

I’m not smart enough to figure that one out Robyn.

Robyn Karnauskas - Deutsche Bank

Well, I was curious like as you did highlight on the quarter call about the indication statement and how you actually even Merck has the word nausea and they are approved for nausea. I was curious to even nurses and doctors understand that their drug hasn’t really proven effected for no significant nausea, do they understand the data well enough how much education will require to say you are different, if you hit on nausea that you are differentiated versus Merck’s in that.

Lonnie Moulder

Yes I think and this has been repeated over the years a number of times and some of the data sets that have been accumulated have actually been presented even in oral presentations at ASCO that there is a perception of how patients feel when they go home after chemotherapy. And then there is the reality that the patients will report if they’re asked and there is a pretty big gap of relative to nausea. So delayed nausea is clearly an unmet need, we know that because patients do go home and they don’t feel well and they don’t call back to the clinic and complain because one, they think that they’re supposed to feel bad, and two, they’re concerned that if they complain either the dose maybe reduced or something will be changed and they are potentially choired of therapy. So the patients don’t complain.

What we did previously in this marketplace is worked very closely with the nurses, because nurses in the chemo clinic are who interact with patients, the doctors see them read their labs from time-to-time but if the nurse that are right there in the chemo clinic and when the patients finish with their chemo it’s the nurse that’s the last person they see as they exist. So, ensuring you’re educating and engaging the nurses so that they’re having that dialogue with the patients and giving them the okay, if you don’t feel well, let me know. And what we found with Aloxi is there was enough of that then the nurses become the biggest affricates okay instead of asking the patients, well it’s okay if you call me up and let me know if you’re not feeling well, they had so many calls they just decided okay, we need to use this drug because these patients aren’t doing as well as we think when we ask them. So, that’s how Aloxi ramps up and that’s how we would anticipate educating nurses around Rolapitant.

And that sort of on the back-end of the commercial strategy on the front-end though I’ll go back to what I said earlier, it’s putting it into the pathways. Just taking the clinical data generated by the oncology networks that we worked, putting the business relationship in place and then having the drug in the pathway so it’s automatically the medical record when a regimen is prescribed by a doctor that fits under those guidelines or pathways. So you pull those two together and that’s what we believe would lead to success.

Robyn Karnauskas - Deutsche Bank

Okay. What percentage of patients are dose reduced because of CINV?

Lonnie Moulder

Off the top of my head I can’t give you that answer. There was a time I probably remembered that.

Robyn Karnauskas - Deutsche Bank

So, I was just curious because you did -- I think it was the quarter call you made a comment about like how you could maybe get an additional two out of 10 patients to get treated for CINV, I was just wondering like where that came from and then…

Mary Lynne Hedley

That’s to be projected.

Robyn Karnauskas - Deutsche Bank

To be protected?

Mary Lynne Hedley

Right, so rather than having 70% of patients protected from CINV, you have 90% of patients to protect.

Robyn Karnauskas - Deutsche Bank

So you get better protected. So, then if you think about what are payors looking for, what is the most important, what do think would be the thing that would guarantee reimbursement in the presence of a generic EMEND is it, if I lift these three things what is the most important, the percentage of people protected by CINV, CYP interaction or more significant nausea, what is the most important driver?

Lonnie Moulder

It is a mix, first of all to clarify, a generic EMEND for the oral will come sometime probably late 2015 with a single player Sandoz and then followed up by multiple players. That’s 20% of the brand and then 80% is the IV and remember IV EMEND is a different chemical entity, it’s not aprepitant it’s a pro-drug prior to aprepitant and that new chemical entity has longer path life, it goes into 2019. So, what we’re talking about is I think is in the near-term the overall formulation of the EMEND which is the three-day regimen. First of all, the patients have to take it for three days and we know over multiple years that's just problematic. So it leads to a poorer outcomes because they have to comply on day two and three, where they have to feel well enough to swallow a capsule on day two and three. So there's some differentiation right there. In addition I think the drug interaction piece I mentioned before is important and of course, if we have the nausea benefit, we’ll be promoting the benefit of our own product in that area and I think that will play into it. So there're several variables there. I can't necessarily weight them, and underpinning all of that is the business relationship with Trinity Oncology.

Robyn Karnauskas - Deutsche Bank

Got it. You also mentioned that some pairs prefer orals. I was just curious why?

Lonnie Moulder

Yes, so there was a an initiative several years back because of the thought that economically more money is going out the door to reimburse physician practices for administering an IV product because there's an effusion fee associated with it and there's the ASP plus 6 system, which right now is ASP plus 4. And this is, we're all talking about Medicare, we are talking about Medicare now. Medicare is about 50% of the reimbursement for the patient population we’re talking about. So it was determined maybe somewhat close minded that oral would cost less to the system, although oral then results in economics flowing into pharmacies, right, for a dispensing fee, and everything that happens in that distribution channel leading up to a pharmacy, but a number of plans put in place a policy that if there was an oral and an IV available, you must use the oral first, and there are few plans in Florida, New Jersey, New York, California, I think another one in the country, and that's been pretty constant. So the market in CID is settled out to be 80% IV, 20% oral, and I think that oral segment is probably pretty solid because of policies such as that.

Now the grower more oral will be driven over time, well that hasn't really evolved in the last several years. This was put in place a couple of years ago and it’s pretty much settled in. So someday could the oral market not be 20%, could it be 25%? I could imagine that. But that's about it. I don’t see a dramatic shift. Does that make sense?

Robyn Karnauskas - Deutsche Bank

That's helpful, I think I've some questions, those of you in the audience, please feel free. I have some anonymous questions. Are we going to get CINV data before December 20th?

Lonnie Moulder

Someone must be going on vacation.

Robyn Karnauskas - Deutsche Bank

I think it's probably vacation, that’s probably [indiscernible] I think so,….

Mary Lynne Hedley

We accelerate holidays at Tesero. We just work straight ….

Robyn Karnauskas - Deutsche Bank

Good to know that poor person will not be going on vacation. Is there a role, this is another question on NK1 applications. Is there is role for NK1 in the prophylactic perioperative management of nausea and vomiting.

Lonnie Moulder

Absolutely. In fact [indiscernible] has an indication there, a large randomized placebo controlled phase 2 study. Rolapitant was conducted in that setting, but we at Tesoro are an oncology focused company and we are not advancing that.

Robyn Karnauskas - Deutsche Bank

I was just wondering of the sale, right now, just in general for 5-HT3s, any drugs that prevent CINV, what percent are really on label?

Multiple speakers

Lonnie Moulder

There is a fair amount of Zofran over the years that's been used in different settings. Zofran's probably the one that's been used most outside of its post-operative nausea and vomiting and chemo induced nausea and vomiting label. Aloxi, which still dominates CINV with over a 50 share, I think virtually all of its use is in CINV.

Mary Lynne Hedley

Same for the NK1 receptor antagonist. That must go on label.

Unidentified analyst

Robyn, could I jump in. So when you comment, it sounds like there is a guideline for the treatment of these patients, but many patients are not treated. Is that the scenario, so, can you what’s the -- what's going on there? Why are so many patients untreated and how are you going to change that. A lot of -- a guideline where a lot of patients are untreated is not that common a scenario.

Lonnie Moulder

It isn't and we see that as a real opportunity. How often is it you get to launch into a class where the experts in the field and all the scientific data points to this is how patients should be treated and all you're looking to do is have the class uptake achieve that. We’re not overreaching at all, just get compliance with guidelines and it goes back to what I said earlier, there is a level of misperception by the general treating clinicians as to what the reality is for patients experience and what their perception is because once again, the physician sees them periodically, not even in the chemo clinic often and then the patients go home. And the only way the physician knows is if the call is first made by patient, gets to the nurse and the nurse then shares it up with physician. So the physicians are two steps removed in many cases. So they have a certain perception and a certain amount of apathy associated with that, and again and I don’t want to keep bringing this up but I will, our experience with Aloxi, as the IV, the launch 5-HT3 receptor antagonist, we’ve really helped to establish the concept of delayed nausea and vomiting. At the time delayed nausea and vomiting wasn’t even spoken about, except for by a handful of top opinion leaders in the world and then it became established. Okay, so this is a long acting 5-HT3 receptor antagonist, just give one dose prior to chemo, I'm going to block serotonin which I think is a really relevant mechanism, so let’s do that. And half the people got on board pretty quickly. Now, we have a similar situation, where a number of the patients, from a nausea standpoint 4 to 5 out of every 10 are home suffering from nausea.

The doctor is two steps removed. From a vomiting standpoint two or three are at home vomiting and the doctor doesn’t have that reality, that connection, and I’m not at all diminishing how well they know their patients. It’s just the way the system works. So it’s our job to take the guidelines and to educate and to work with the leading networks in the country who worked on our clinical studies to put pathways in place like they have pathways in another areas that comply with guidelines and we think that’s very doable.

Unidentified analyst

So the thought is that to sort of entice nurses and patients, to believe the patients could feel better when they go home is that you see the part of the drug development process? Maybe I misunderstand?

Lonnie Moulder

It’s to engage the nurses and together help the physicians understand and at the same time work with the leadership of the networks, where the pathway decisions are made and then put down into the system. So it’s really to work it from both ends.

Unidentified analyst

Thank you.

Robyn Karnauskas - Deutsche Bank

One last question on Rolapitant for me is – so what is your philosophy on when you launch a product, how soon do you think you will be able to predict like the three-year trajectory and officially given that you’re launching in oral first, will you know enough about the peak potential or whether or not your assumptions for your peak potential are on track from the oral launch or do you have to wait for your launch of the IV?

Lonnie Moulder

I think as we just get a few quarters into the launch, you have a sense internally of what you think the peak would be. The question would be from an investor relations standpoint, do we want to be out there and put a steak in the ground around that peak.

Robyn Karnauskas - Deutsche Bank

You don’t have to. I'm just curious whether you will know.

Lonnie Moulder

Internally, I think we have a pretty good sense of it.

Robyn Karnauskas - Deutsche Bank

Even though, you haven’t launched. Okay I just want to transfer you one quick question on the PARP. So there was a competitor that highlights the fact that they see a CR in their data as having greater potency for their PARP and I was just wondering like what are your thoughts, what is CR versus PR mean in the PARP world? Does that mean to more potent? I get this question a lot. Well, this drug has CR, so it’s more potent.

Mary Lynne Hedley

Well, I would start up by saying, if it was my scientific answer, which is I think it’s really too early for any of us to be saying that we have clinical data that is frankly very differentiated from anybody else. Right, it’s early days, it’s clinical data, it’s in 100 of your patients and at the recommended Phase 3 doses. Really, it’s handful of the patients that we’re talking about. So that’s my scientific answer. If I had to pick a PARP inhibitor, which one would I take answer – it would be mine of course.

Robyn Karnauskas - Deutsche Bank

Thank god, you saw that.

Mary Lynne Hedley

And why and I think that’s because if I look at the ovarian setting and this again, small numbers of patients, I have 75% research and that’s critical research response rate in the same patient population that I’ll be treating in my Phase 3. So with the dose and the patients that I will be treating, the ovarian cancer patients, platinum-sensitive high-grade serous, 75% research response rate is pretty good and it’s better than I’ve seen reported anywhere else for anybody, potentially more potent PARP inhibitor.

In the breast cancer setting, I have a 50% research response rate and these again all in patients that have been treated with multiple lines of chemotherapy. In the ovarian settings, those are patients that have been treated with median of six prior lines of chemotherapy. I think one of the competitor’s expansion cohort was in patient who were being set, two or three lines of previous chemotherapy was the median. So I have a better response in [indiscernible] patients. In the breast cancer study the median number of previous treatments was five and other people two to three. So then we look at the tolerability profile and I think if you talk to breast cancer patients who are getting chemotherapy, one of the things that they hate the most is alopecia. And we know one of the competitors has alopecia at a 10% or so response level. So does that mean that’s going to happen in the Phase 3? Back to my scientific answer, I don't know that. But again based on the profile that I’ve seen today I am very pleased with the PARP inhibitor that we have and it's the one that I would want to take forward into Phase 3.

Robyn Karnauskas – Deutsche Bank

How is enrollment in NOVA going?

Mary Lynne Hedley

We don't update on enrollment, I am sorry rather. But -- and it's too early for me to tell when we'll be done with enrollment and when I will be filing the NDA.

Robyn Karnauskas – Deutsche Bank

So there wasn't a lot of single agent activity seeing with fiber and PARP and you are doing a combination trial. Just help us understand what is the risk ground side effects when you are combining a PARP and whether or not it will be at all tolerable combination? And then what is the rationale in doing -- for using a combination versus why monotherapy wouldn’t work?

Mary Lynne Hedley

So people who are really in a particular sarcoma consortium, was this is an international consortium focused on treatment of sarcoma patients. We're very excited about the preclinical data that came out with PARP inhibitors about 1.5 year ago, which showed, in these particular patients, which 98% of them have a particular fusion protein and PARP interfaces with that fusion protein to drive transcription of certain genes, which cause the tumor cells to grow.

Anyway the preclinical data was very exciting. So they pull together a consortium or a group of companies working PARP inhibitors inside, tell us about PARP inhibitors and what we could potentially do in the clinic. And so we attended that and after that meeting had decided and they decided to work with us to advance the concept of a PARP inhibitor in sarcoma patients.

And so the excitement was around the preclinical data. I think the concept originally was around monotherapy. I think that's very challenging in sarcoma because the patients are initially treated with a slew of chemotherapy agents and radio therapy. In a second line setting, they often progress pretty quickly. There is no known treatment that's really effective.

So I think putting a PARP inhibitor in a monotherapy setting in that particular case would be tough, and I think the preliminary early data for people – I’m including biomarine has been monotherapy, not been as successful as we would have liked to see. So we backed about a year ago, started talking to -- sort of about potentially combining. But I didn’t – I wasn’t at all interested in combining in the traditional way people have combined PARP inhibitors and that way as you know is to take full dose chemotherapy and add in full dose chemotherapy or titrate and PARP inhibitors and inevitably stop because of myelosuppression, because PARP inhibitors when combined with these chemotherapy agents, which also cause myelosuppression, you can't get past the myelosuppression, you can't get a full dose PARP. I’ve never seen a full dose PARP given with full dose chemotherapy. And you can't reduce the chemotherapy because the chemotherapy is known to have a positive outcome. So what doc in their right mind is going to reduce the chemotherapy to give full dose PARP?

So you had -- sarcoma represented an opportunity to try initially some full dose PARP, but to start to titrate in the chemotherapy. And what this will do is enable us to think PARP inhibitors in a totally different way. You are actually using the chemotherapy to sensitize to the PARP inhibitor, because PARP inhibitors take a while to work because of the mechanism. It's not like cytotoxic chemotherapy, they don't work just instantly.

So if you can start with full dose PARP and titrate in a chemotherapy and you can do it in the sarcoma study because there is no approved second line chemotherapy that are currently used, [indiscernible] you have a way of potentially exploring an entirely new way to PARP inhibitors and you may actually really benefit these sarcoma patients and lot of our kids, that would be great. But it also gives you the ability to take this information and then apply it in other indications.

So I think it serves at least three purposes, one to learn about whether or not PARP inhibitors can really work as monotherapy in sarcoma, two to be able to really potentially benefit sarcoma patients with a combination that might work and three take the learnings and apply them to other indications where those chemotherapies might be useful but are not approved. And so you potentially expand the opportunity for truly doing combination therapies.

Robyn Karnauskas – Deutsche Bank

Could you actually go back into breast and ovarian?

Mary Lynne Hedley

Possibly.

Robyn Karnauskas – Deutsche Bank

Very fine. Great, thank you very much.

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